Study identification

EU PAS number

EUPAS25164

Study ID

25165

Official title and acronym

A Multinational, Prospective, Observational Study of the Effectiveness, Healthcare Resource Utilization and Costs in Patients with Rheumatoid Arthritis Receiving Baricitinib, Targeted Synthetic or Biologic Disease‑Modifying Therapies (RA-BE-REAL)

DARWIN EU® study

No

Study countries

Australia
Brazil
Canada
France
Germany
Italy
Saudi Arabia
Spain
United Kingdom

Study description

This is a prospective noninterventional 2-cohort study. Cohort A comprises patients with rheumatoid arthritis (RA) starting baricitinib for the first time at any point in the treatment algorithm, and Cohort B comprises patients starting treatment with any other targeted synthetic disease-modifying antirheumatic drug (tsDMARD), or a biologicaldisease-modifying antirheumatic drug (bDMARD) for the first time at any point in the treatment algorithm. The aim of the study is to define a patient profile of patients with RA starting baricitinib, other tsDMARDs, or bDMARDs for the first time, describing their patient characteristics as well as clinical and patient-reported outcomes (includinghealth related quality of life HRQOL and patient’s assessment of pain), healthcare resource utilization (HRU) and costs. The study will also describe how these treatments are used in a real-world setting by assessing treatment patterns.

Study status

Planned
Research institutions and networks

Institutions

Syneos Health
United Kingdom
First published:
06/03/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Walid Fakhouri

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Company
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable